Progesterone tablet and its manufacturing process

Abstract

The invention concerns a progesterone tablet characterised by the fact that its excipient content is at most 45%, preferably at most 40%, and yet more preferably at most 38%, the percentages being expressed in weight relative to the total dry matter of the tablet.

Description

The present invention concerns a progesterone tablet as well as a process for its manufacture.Natural progesterone is a hormone which, in women, is synthesized mainly by the ovary and, to a lesser degree, by the adrenal glands and the placenta during the second part of pregnancy. Non endocrine synthesis of progesterone, particularly at the level of neurones, is also possible.Insufficient progesterone secretion in a woman may lead to various disorders, in particular:premenstrual syndromes,menstrual irregularities through disovulation or anovulation,benign mastopathies,premenopause,menopause.For the latter indication, progesterone is administered as a complement of an oestrogenic treatment.Oral administration of progesterone is severely jeopordised because of its high rate of metabolization by the liver.Yet oral administration has certain obvious advantages compared with other methods of administration. On the one hand it is more practical than vaginal administration, and on the other...

AI Technical Summary

Benefits of technology

Quite surprisingly and unexpectedly, although they contain significantly lower quantities of excipients than tablets of the prior art, the tablets developed by the Applicant Company nevertheless show excellent properties of stability, hardness, disintegration and dissolution.

Pregelatinized maize starch is a starch that has been physically modified in order to allow a fluid flow and be directly compressible. It therefore has many advantages in the manufacture of tablets, including improved dissolution and self-lubrication.

Microcrystalline cellulose has good free flowing qualities. Moreover it has good properties as a binding and disintegrating agent, and is thus an ideal excipient for the manufacture of tablets by direct compression.

The preferred binding agents in the context of this invention include polyvinylpyrollidones, particularly the product marketed under the trademark Polyvidone K30. This product allows quasi immediate release of the active constituent, and is moreover very easy to use.

One of the advantages of the tablet that is the object of the invention is that its disintegration time is less than 15 minutes, preferably less than 10 minutes, and yet more preferably less than 5 minutes.

Problems solved by technology

Oral administration of progesterone is severely jeopordised because of its high rate of metabolization by the liver.

On the one hand it is more practical than vaginal administration, and on the other hand it allows the medication to be taken independently, which is not possible in the case of parenteral administration.

The process for manufacturing such capsules has however proven to be both complex and costly to implement, and requires considerable know-how.

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